Objective Markers of Pain Perception in Pediatric Emergency

Suffering, Physical Clinical Trial

— TAMALOU  

Official title:

Objective Markers of Pain Perception in Pediatric Emergency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145454
• Other study ID #: 1608198
• Secondary ID: ANSM
• Status: Completed
• Phase: N/A
• Start date: May 4, 2017
• Est. completion date: July 17, 2018

Study information

• Verified date: October 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Requiring one or more non-complex sutures in department of pediatric emergency

• Affiliate or beneficiary of social security (parents)

• Signature of consent (parents)

Exclusion Criteria:

• Historic of cardiovascular diseases (arterial hypertension, etc), renal or metabolic syndrome (diabetes etc.), psychiatric (depression, etc.) or neurological (epilepsy seizure, etc.)

• Trouble of heart rhythm

• Allergy at conductive gel for electrode

• Sutures requiring a general anesthesia

• Contraindication at the Xylocaine and/or Paracetamol

Related Conditions & MeSH terms

• Emergencies
• Pain
• Stress, Psychological
• Suffering, Physical

Intervention

Device:
• electroencephalography helmet
electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.
• dermal electrode
dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.
• blood pressure sensors
blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.
• Pupillometry glasses
Pupillometry glasses will be performed during surgical gesture to determine the pain of child.
• Holter
Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of alpha spectral power	Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.	During the surgical gesture
Secondary	Rate of spectral power low and high frequency	Rate of spectral power low and high frequency according to heart frequency variability result.	During the surgical gesture
Secondary	Amplitude of the dermal responsiveness	Compare amplitude of the dermal responsiveness according to dermal electrode result.	During the surgical gesture
Secondary	Amplitude of the pupillary diameter	Compare amplitude of the pupillary diameter according to pupillometry glasses result.	During the surgical gesture